Introduction to Northern Ireland Adverse Incidents Centre (NIAIC)

Northern Ireland Adverse Incidents Centre (NIAIC)

General Background

The Northern Ireland Adverse Incident Centre (NIAIC) operates within the Department of Health (DoH) and currently has the dual role of monitoring the safety of medical devices, estates plant/building elements and to provide safety information and guidance in this area.

The key aim of the NIAIC is to seek learning from the manufacturers following reported adverse incidents involving medical devices and estates and facilities equipment used within the healthcare environment across Northern Ireland and to issue safety information and guidance to reduce the risk of recurrence.

Adverse Incident Reporting

The NIAIC would seek to promote a shift to a non-blame safety culture, where open reporting and balanced analysis is encouraged. This has been proven in many instances to provide additional learning and product improvement. This contrasts with a blame culture, where people cover up errors for fear of retribution. NIAIC adverse incident reporting - guidance and forms

The NIAIC works closely with: -

  • the Medicines and Healthcare products Regulatory Agency (MHRA), the UK Competent Authority for Medical Devices, by mirroring medical device incident reports from Northern Ireland for inclusion on the national register to assist trending.
  • manufacturers - by informing them of issues with their products, monitoring their response and providing learning back to the service areas.
  • devolved partners - NHS England Estates and Facilities, Health Facilities Scotland, and NHS Wales Shared Services Partnership – to share safety issues concerning estates nonmedical equipment, plant and building items.

Distribution of Safety Information

Where generic learning comes in the form of alerts or safety notices, this is distributed to the wider healthcare environment via the Northern Ireland Central Alerting Systems

(NICAS). The NICAS is a web-based application to notify users and the public about new or updated safety information. Safety Information can take the form of: -

National Patient Safety Alerts – Medical Devices (NaPSA)

The Medicines and Healthcare products Regulatory Agency (MHRA) the UK Competent Authority for Medical Device, is an accredited issuer of National Patient Safety Alerts. National Patient Safety Alerts are alerts that require local executive management level action to reduce the risk of death or serious harm. These alerts follow the criteria and template agreed by the National Patient Safety Alerting Committee (NaPSAC), they are not limited to medical device issues. Therefore, MHRA medical device alerts will be interleaved with other Patient Safety Alerts and their reference numbers for medical device alerts may not hold a consecutive reference number.

Device Safety Information (DSI)

The MHRA will continue to provide a range of other medical device safety guidance at a lower level in the Device Safety Information (DSI) format. These do not require local executive management assurance, but they can contain “Actions” that the Trusts may require to implement to protect patient and users’ safety. Medical Device Alerts (MDAs) are no longer issued, although the NICAS websites will continue to display a list of those alerts that are still current, with links to the original documents. If an MDA is not listed, it may have been either superseded or withdrawn.

General Medical Device Information

These take the form of Medical Device Safety Bulletins, Guidance Reports, and general safety information, they will be published on the MHRA section of the .gov website. Although the MHRA may introduce additional formats at any time to meet specific needs.

Estates and Facilities Notices (EFN)

Estates and Facilities Notices (EFNs) are produced nationally and distributed by the NIAIC to the Northern Ireland healthcare community. They contain safety information on estates issues that may provide new learning or reinforce safety information. EFN’s now supersede EFA’s that were introduced at the start of 2010 as a national estates and facilities alerting system, they are simultaneously published in England, Wales, Scotland, and Northern Ireland. The alert in each of the Devolved Administrations will carry the same reference number.

Northern Ireland Safety Notices (NISN)

Northern Ireland Safety Notices (NISNs) are the NIAIC’s means of communicating safety information for either medical devices or estate and facilities. They are only published in Northern Ireland and are designed to give advice on local issues or advanced notification of safety problems still under national investigation i.e., they may be superseded by national advice at some point in the future.

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